In-senior Associate_csv_itra_advisory_mumbai

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Mumbai, India
4-8 years computer system validation experience
Gamp5 guideline and gxp knowledge
Us fda 21 cfr part 11 compliance
The role focuses on providing independent assessments of financial statements, internal controls, and ensuring compliance with regulations like US FDA 21 CFR Part 11

Job Summary

  • The role focuses on providing independent assessments of financial statements, internal controls, and ensuring compliance with regulations like US FDA 21 CFR Part 11.
  • Candidates will be part of a vibrant community that leads with trust, creating distinctive outcomes while harnessing AI and other risk technologies.
  • The position offers inclusive benefits, flexibility programmes, and mentorship designed to help employees thrive in work and life.

Matching Summary

The role focuses on providing independent assessments of financial statements, internal controls, and ensuring compliance with regulations like US FDA 21 CFR Part 11.

Skills & Requirements

Must-have

  • 4-8 years Computer System Validation experience
  • GAMP5 Guideline and GxP knowledge
  • US FDA 21 CFR Part 11 compliance
  • Manual testing and defect tracking
  • Validation deliverable authoring

Nice-to-have

  • Exposure to Valgenesis CSV tools
  • LIMS or QMS system experience
  • Agile and Waterfall methodology knowledge
  • AI and risk technology delivery models
  • Inclusive benefits and mentorship culture

Key Requirements

  • Bachelor of Engineering degree required
  • 4-8 years of relevant work experience
  • Knowledge of SDLC and STLC methodologies

Work Rights

Not specified

Tailored Resume

Cover Letter